The FDA Guidance of Risk-Based Approach to Monitoring as viewed from CDM
by DATATRAK International, Inc. on May 07, 2012
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- Interactions: Sponsors, Clinical Operations and CDM ...
- Interactions: Sponsors, Clinical Operations and CDM
- Risk-Based Monitoring
- Challenges for Sponsors
- Challenges for Monitors
- Challenges for CDM
- Implementation – Will there be any affect on data quality or integrity?
- Will the Risked-Based Approach require roles/skill set adjustments?
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